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目的建立测定罗红霉素缓释胶囊释放度的高效液相色谱(HPLC)法。方法采用Waters X-Bridge-C_(18)色谱柱(4.6 mm×250 mm,5μm),流动相为0.067 mol·L~(-1)磷酸二氢铵溶液(三乙胺调节pH至6.5)-乙腈=60∶40(V/V),流速为0.6 mL·min~(-1),检测波长为210 nm,柱温35℃。结果罗红霉素在0.01~1.00 mg·mL~(-1)浓度范围内与峰面积呈良好的线性关系,平均回收率为101.1%,RSD为0.8%。结论所建立方法快速、灵敏,结果准确可靠,可用于罗红霉素缓释胶囊释放度的测定。
Objective To establish a high performance liquid chromatography (HPLC) method for the determination of roxithromycin sustained-release capsules. Methods A Waters X-Bridge-C_ (18) column (4.6 mm × 250 mm, 5 μm) was used. The mobile phase was 0.067 mol·L -1 ammonium dihydrogen phosphate solution (triethylamine adjusted to pH 6.5) Acetonitrile = 60:40 (V / V), the flow rate was 0.6 mL · min -1, the detection wavelength was 210 nm and the column temperature was 35 ℃. Results Roxithromycin had a good linear relationship with the peak area in the concentration range of 0.01-1.00 mg · mL -1 with an average recovery of 101.1% and a RSD of 0.8%. Conclusion The method is rapid and sensitive, and the results are accurate and reliable. It can be used to determine the release of roxithromycin sustained - release capsules.